a study to evaluate if aticaprant added to a current antidepressant and given up to one year is safe and would help improve depression.

Phase 1

• Conditions: Major Depressive Disorder (MDD); MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2022-000430-42-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

Transferred patients:
- Participants must have completed the Double Blind Treatment Phase of
Study 67953964MDD3001 or Study 67953964MDD3002 study.
- Participant must be medically stable on the basis of physical
examination, medical history, vital signs (including blood pressure), and
12-lead ECG performed at baseline and prior to Open Label treatment
initiation.
Direct entry patients:
- Male or female, aged 18 to 74 years of age, inclusive.
- Be medically stable on the basis of physical examination, medical
history, vital signs, and 12-lead ECG performed at screening and baseline
- Be medically stable on the basis of clinical laboratory tests performed
at screening
- Meet DSM-5 diagnostic criteria for recurrent or single episode MDD,
without psychotic features. Participants 65 years of age or older must
have had the first onset of depression prior to 55 years of age.
- Have had an inadequate response to at least 1 oral antidepressant
treatment, administered at an adequate dose and duration in the current
episode of depression.
- Is receiving and tolerating well a SSRI/SNRI for depressive symptoms
at screening, at a stable dose for at least 6 weeks
- Have a HDRS-17 total score of 20 or higher at the first and second
screening interviews and must not demonstrate a clinically significant
improvement between the first and the second independent HDRS-17 assessments
Please refer to study protocol for full list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 672
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

Transferred-entry participants:
- Participant has been non-compliant with the study intervention
administration in the Double Blind (DB) Treatment Phase in either of
Studies 67953964MDD3001 or 67953964MDD3002
- The evaluation of the benefit versus risk of continued aticaprant
treatment is not favorable for the participant in the opinion of the
investigator.
- Participant is reporting suicidal ideation with intent to act or suicidal
behavior at baseline.
- Participant has taken any prohibited therapies that would not permit
dosing on Day 1, as noted in the pre-study and concomitant therapy
section.
- Participant has any condition or situation/circumstance for which, in
the opinion of the investigator, participation would not be in the best
interest of the participant (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
Direct-entry participants:
- Have had in the current depressive episode, no response (treatment
failure) to 5 or more antidepressant treatments including the current
SSRI/SNRI
- Has a history or evidence of clinically meaningful noncompliance with
current antidepressant therapy.
- Has a history of moderate-to-severe substance use disorder including
alcohol use disorder according to DSM-5 criteria within 6 months before
screening
- Has had in the current episode an inadequate response to adequate
course of intravenous or intranasal ketamine or esketamine,
electroconvulsive therapy (i.e, at least 7 treatments), vagal nerve
stimulation, or a deep brain stimulation device
- Has a current homicidal ideation/intent, per the investigator's clinical
judgment, or has suicidal ideation with some intent to act within 3
months prior to the start of the screening phase
Please refer to study protocol for full list of exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of aticaprant ;Secondary Objective: To assess the long-term efficacy of aticaprant;Primary end point(s): * AEs including AEs of special interest (AESI)<br>* Change from baseline in vital signs<br>* Weight/body mass index (BMI)<br>* Suicidality assessment using the Columbia Suicidality Severity Rating<br>Scale (C-SSRS)<br>* Laboratory parameters<br>* 12-lead ECG<br>* Assessment of withdrawal symptoms using the Physician Withdrawal<br>Checklist, 20-item (PWC-20).<br>* Proportion of participants with clinically relevant sexual dysfunction<br>over time in the Arizona Sexual Experiences Scale (ASEX) score.;Timepoint(s) of evaluation of this end point: Throughout the study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Depressive Symptoms, anhedonia symptoms, severity of depressive illness;Timepoint(s) of evaluation of this end point: starting at baseline, ending at follow-up